<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20120814010599N13</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-12-21</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of dexamethasone on blood glucose concentration</public_title>
      <acronym></acronym>
      <scientific_title>A comparative study on the effect of different doses of dexamethasone on blood glucose concentration in patients undergoing elective abdominal surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28011</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients who are included in the study are divided into three groups based on the randomization block using a random number table, Blinding description: The patient does not know which medicine he receives. The nurse is aware; the researcher like the patient does not know which patient is in what group and which method he receives. The counselor, as well as the nurse, knows which patient, which method Receives.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Hyperglycemia due to steroid.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1 : . Before the intervention, blood glucose and other basic indicators are checked. 32 patients  In a group ,4 mg intravenous dexamethasone is injected at the beginning of the surgery, The drugs are prepared by the operating room pharmacy in 3 ml syringes labeled as patient name. . After surgery, blood glucose levels were measured and recorded by the nurse at 6 hours and 24 hours after administration of dexamethasone or placebo. Intervention 2: Intervention group 2 : . Before the intervention, blood glucose and other basic indicators are checkedand. 32 patients  in the second group, 8 mg dexamethasoneare injected. The drugs are prepared by the operating room pharmacy in 3 ml syringes labeled as patient name. After surgery, blood glucose levels were measured and recorded by the nurse at 6 hours and 24 hours after administration of dexamethasone or placebo. Intervention 3: Control group: Before the intervention, blood glucose and other basic indicators are checked. 64 patients in the third group, placebo (normal saline) are injected. . The drugs are prepared by the operating room pharmacy in 3 ml syringes labeled as patient name.. After surgery, blood glucose levels were measured and recorded by the nurse at 6 hours and 24 hours after administration of dexamethasone or placebo.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Data file of people not identifiable, protocol of doing the study,How to analyze data,informed consent from individuals, A report from a clinical study and its outcome

When:
Start the access period : 1 month after printing results

To whom:
Researchers working in academic centers

Conditions:
Specific conditions for use by individuals will not be considered

Where to obtain:
Contact Dr. Mehrdad Khodabandeh by email khadabandeh.mehrdad@gmail.com

How to obtain:
By sending an email and requesting the request, after a day, the information will be sent to the person

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Poupak Rahimzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613131</zip>
        <telephone>+98 21 8670 2503</telephone>
        <email>p-rahimzadeh@tums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Poupak Rahimzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613131</zip>
        <telephone>+98 21 8670 2503</telephone>
        <email>p-rahimzadeh@tums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All people  who are candidates for abdominal surgery</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>cardiovascular patients
Recent history of steroid use
History of allergy to any of the drugs used in the study.
pulmonary patients
renal patients
hepatic patients
DM patients</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T38.0X5A</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Adverse effect of glucocorticoids</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1 : . Before the intervention, blood glucose and other basic indicators are checked. 32 patients  In a group ,4 mg intravenous dexamethasone is injected at the beginning of the surgery, The drugs are prepared by the operating room pharmacy in 3 ml syringes labeled as patient name. . After surgery, blood glucose levels were measured and recorded by the nurse at 6 hours and 24 hours after administration of dexamethasone or placebo.</i_keyword>
      <i_keyword>Intervention group 2 : . Before the intervention, blood glucose and other basic indicators are checkedand. 32 patients  in the second group, 8 mg dexamethasoneare injected. The drugs are prepared by the operating room pharmacy in 3 ml syringes labeled as patient name. After surgery, blood glucose levels were measured and recorded by the nurse at 6 hours and 24 hours after administration of dexamethasone or placebo.</i_keyword>
      <i_keyword>Control group: Before the intervention, blood glucose and other basic indicators are checked. 64 patients in the third group, placebo (normal saline) are injected. . The drugs are prepared by the operating room pharmacy in 3 ml syringes labeled as patient name.. After surgery, blood glucose levels were measured and recorded by the nurse at 6 hours and 24 hours after administration of dexamethasone or placebo.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood glucose levels. Timepoint: After surgery, at 6 hours and 24 hours after administration of dexamethasone or placebo. Method of measurement: Blood glucose is measured using a glucometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-12-09</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Science</contact_name>
        <contact_address>Iran University of Medical Sciences,next to Milad Tower,Hemmat Highway,Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
